MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, SUPERLIGHT, BLACK

Catalog Number MDS86825SLBLK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Rollator wheel fell off causing fall which caused customer to require physical therapy.

Manufacturer Narrative

On 12/9 it was reported that at some time, the rollator wheel came off.Per the customer, he needs the device to get to the bus stop so he was using the product with only three wheels.He reported that when he went to step off a curb, he lost his balance and fell.Customer reports he had to go to the emergency room via ambulance.He was given ibuprofen and a sling.He reports he is requiring physical therapy due to the fall.Customer reports he received the product through insurance and it is about a year old.The sample was not returned to the manufacturer, therefore no root cause could be established.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: ROLLATOR, SUPERLIGHT, BLACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16061040
• MDR Text Key: 306262965
• Report Number: 1417592-2022-00247
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86825SLBLK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other